Systems and methods for fluid delivery manifolds

ABSTRACT

A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold configurations that meet specific needs (i.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit and priority to, and is a Continuationof International Patent Application No. PCT/US18/61696 titled “SYSTEMSAND METHODS FOR FLUID DELIVERY MANIFOLDS” and filed on Nov. 16, 2018which itself claims priority to and is a non-provisional of: (i) U.S.Provisional Application Ser. No. 62/587,879 titled “DELIVERY SYSTEM” andfiled on Nov. 17, 2017, (ii) U.S. Provisional Application Ser. No.62/674,565 titled “NFC-Enabled Drug Containing System and AssociatedInformation Layer” and filed on May 21, 2018, and (iii) U.S. ProvisionalApplication Ser. No. 62/680,116 titled “NFC-ENABLED DRUG CONTAININGSYSTEM AND ASSOCIATED INFORMATION LAYER” and filed on Jun. 4, 2018; thecontents of each of which are hereby incorporated by reference herein intheir entirety.

BACKGROUND

Every year, millions of people become infected and die from a variety ofdiseases, some of which are vaccine-preventable. Although vaccinationhas led to a dramatic decline in the number of cases of severalinfectious diseases, some of these diseases remain quite common. In manyinstances, large populations of the world, particularly in developingcountries, suffer from the spread of vaccine-preventable diseases due toineffective immunization programs, either because of poorimplementation, lack of affordable vaccines, or inadequate devices foradministering vaccines, or combinations thereof.

Some implementations of immunization programs generally includeadministration of vaccines via a typical reusable syringe. However, inmany situations, particularly in developing countries, theadministration of vaccines occur outside of a hospital and may beprovided by a non-professional, such that injections are given topatients without carefully controlling access to syringes. The use ofreusable syringes under those circumstances increases the risk ofinfection and spread of blood-borne diseases, particularly whensyringes, which have been previously used and are no longer sterile, areused to administer subsequent injections. For example, the World HealthOrganization (WHO) estimates that blood-borne diseases, such asHepatitis and human immunodeficiency virus (HIV), are being transmitteddue to reuse of such syringes, resulting the death of more than onemillion people each year.

Previous attempts at providing single-use or disposable injectiondevices to remedy such problems in the industry have achieved measurablesuccess but have failed to adequately remedy the existing problems.Pre-filled, single-use injection devices manufactured via injectionmolding or Form-Fill-Seal (FFS) processes, such as the Uniject™ deviceavailable from the Becton, Dickinson and Company of Franklin Lakes,N.J., for example, while offering precise manufacturing tolerances inthe range of two thousandths of an inch (0.002-in; 50.8 μm) to fourthousandths of an inch (0.004-in; 101.6 μm)—for hole diameters in moldedparts, require separate sterilization processes (e.g., gamma radiation)that are not compatible with certain fluids, provide production rateslimited to approximately nine thousand (9,000) non-sterile units perhour, and can be provided to an end-user for approximately one dollarand forty cents ($1.40) per dose/unit.

BRIEF DESCRIPTION OF THE DRAWINGS

An understanding of embodiments described herein and many of theattendant advantages thereof may be readily obtained by reference to thefollowing detailed description when considered with the accompanyingdrawings, wherein:

FIG. 1 is a front view of BFS vial package according to someembodiments;

FIG. 2 is a front view of a fluid delivery manifold according to someembodiments;

FIG. 3 is a front view of a safety cap manifold according to someembodiments;

FIG. 4 is a front view of a safety cap manifold according to someembodiments;

FIG. 5A and FIG. 5B are front and cross-sectional views of a fluiddelivery manifold system according to some embodiments;

FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, FIG. 6E, FIG. 6F, FIG. 6G, and FIG.6H are top-front perspective, top, bottom, left, right, front, back, andcross-sectional views of a fluid delivery hub according to someembodiments;

FIG. 7A and FIG. 7B are cross-sectional views of a fluid deliverymanifold system according to some embodiments;

FIG. 8A and FIG. 8B are cross-sectional views of a fluid deliverymanifold system according to some embodiments; and

FIG. 9 is a flow diagram of a method according to some embodiments.

DETAILED DESCRIPTION I. Introduction

Embodiments of the present invention provide systems and methods forfluid delivery manifolds that overcome the drawbacks of current deliverydevices and methods. For example, the delivery system of someembodiments may include a Blow-Fill-Seal (BFS) package coupled to afluid delivery manifold and/or a safety cap manifold. In someembodiments, an administration member such as a needle may beselectively actuated by application of force to the fluid deliverymanifold and/or a safety cap manifold, causing the administration memberto pierce a fluid reservoir of at least one BFS vial of the BFS package.Utilization of such systems that employ BFS vials and/or a fluiddelivery manifold may be advantageous and may address variousshortcomings of pervious systems.

BFS vials may, for example, offer a less expensive alternative to vialsor devices created via other manufacturing techniques. In someembodiments, BFS vials (e.g., due to the nature of the BFS manufacturingprocess) may not require separate sterilization (e.g., an mayaccordingly be compatible with a wider array of fluids), may provideenhanced production rates of approximately thirty thousand (30,000)sterile/aseptic units per hour, and/or may be provided to an end-userfor approximately forty-five cents ($0.45) per dose/unit. In someembodiments, these advantages may come with an attendant drawback ofreduced manufacturing tolerances. BFS processes may, for example, offerless precise manufacturing tolerances in the range of five hundredths ofan inch (0.05-in; 1.27 mm) to fifteen hundredths of an inch (0.15-in;3.81 mm)—for linear dimensions, e.g., in accordance with the standardISO 2768-1 “General tolerances for linear and angular dimensions withoutindividual tolerance indications” published by the InternationalOrganization for Standardization (ISO) of Geneva, Switzerland (Nov. 15,1989).

According to some embodiments, a single-dose, disposable, and/ornon-refillable fluid delivery device may be provided despite thepresence of the less precise manufacturing tolerances of the BFS vials,by utilization of the systems and methods described herein.

II. Fluid Delivery Manifold Systems

Referring initially to FIG. 1 , for example, a front view of BFS vialpackage 102 according to some embodiments is shown. The BFS vial package102 may, for example, comprise and/or define a plurality ofindividual-dose BFS vials 104 a-g joined, coupled, and/or formedtogether, e.g., as depicted. In some embodiments, and as illustratedwith respect to a first one of the plurality of BFS vial 104 a, thefirst BFS vial 104 a may comprise and/or define a first or proximate end104 a-1 and a second or distal end 104 a-2. Disposed therebetween,according to some embodiments, may be a first BFS vial body 106 a. Insome embodiments, each BFS vial 104 a-g may be coupled (e.g., duringand/or as a by-product of a BFS formation process) to any adjacent BFSvial 104 a-g via the respectively-adjacent BFS bodies 106 a-g. Theconnected series of seven (7) BFS vials 104 a-g depicted in FIG. 1 may,for example, be formed together via a single, seven-compartment BFS moldor die (not shown) during a BFS formation process. In some embodiments,fewer or more BFS vials 104 a-g may comprise and/or define the BFS vialpackage 102, as is or becomes known or practicable.

According to some embodiments, each BFS vial 104 a-g may comprise and/ordefine various features such as features molded, formed, cut, glued,and/or otherwise coupled thereto. As depicted in FIG. 1 for example, thefirst BFS vial 104 a may comprise a first vial neck 108 a (e.g., at ornear the distal end 104 a-2) upon which various mating features areformed (or otherwise coupled). In some embodiments, the first vial neck108 a may comprise a first or distal exterior radial flange 108 a-1and/or a second or proximate exterior radial flange 108 a-2. Accordingto some embodiments, either of the radial flanges 108 a-1, 108 a-2and/or a separate mating feature (not shown) on or of the first vialneck 108 a may comprise a tab or other radial protrusion that permitsindexed mating of the first vial neck 108 a with various othercomponents (not shown in FIG. 1 ). In some embodiments, each of the BFSvials 104 a-g may comprise and/or define a fluid reservoir 110 a-g,e.g., disposed and/or formed on each respective vial body 106 a-gthereof. According to some embodiments, each fluid reservoir 110 a-g maystore, house, and/or accept a single dose of fluid such as one or moremedications, vaccines, solutions, and/or other therapeutic, restorative,preventative and/or curative agents. In some embodiments, a nitrogenbubble (not shown) may be disposed in the fluid reservoirs 110 a-g tofacilitate expelling of all of the fluid in the case that the fluidreservoirs 110 a-g are squeezed and/or compressed by a user (not shown).

Radially inward compressive force applied to a first fluid reservoir 110a of the first BFS vial 104 a may, for example, cause the first fluidreservoir 110 a to collapse radially inward, forcing the fluid storedtherein into a fluid channel 112 a disposed in the first vial neck 108a. The first vial neck 108 a may comprise a tube or passage, forexample, that but for a fluid seal 112 a-1 disposed at the distal end104 a-2, would form an opening at the distal end 104 a-2 through whichthe fluid may flow when expelled from the first fluid reservoir 110 a.In some embodiments, the first vial body 106 a may comprise and/ordefine a flat or grip portion 114 a disposed between the first fluidreservoir 110 a and the proximate end 104 a-1 of the first BFS vial 104a. The grip portion 114 a may, for example, comprise a flat element thatpermits axial force to be applied to the first BFS vial 104 a withoutcausing such axial force to be applied to the first fluid reservoir 110a (e.g., for engaging an administering element (not shown) as describedherein).

In some embodiments, the BFS vial package 102 may comprise an indiciaimprinting thereon (and/or therein) and/or upon each individual BFS vial104 a-g (e.g., on the grip portion 114 a of the first BFS vial 104 a).Exemplary indicia may include, but is not limited to, lot number,expiration date, medication information (e.g., type, quantity, etc.), asecurity stamp (color changing temperature sensor to provide indicationof whether BFS vials 104 a-g have or have not been maintained atrequired temperature), as well as a dosage and/or measurement lineprovided on each BF vial 104 a-g. While seven (7) BFS vials 104 a-g aredepicted in FIG. 1 as being coupled to and/or comprising the BFS vialpackage 102, fewer or more BFS vials 104 a-g may be coupled to the BFSvial package 102 as is or becomes desirable and/or practicable.

According to some embodiments, the BFS vial package 102 and/or one ormore of the BFS vials 104 a-g may comprise and/or be coupled to one ormore electronic devices 116 a-g. The electronic devices 116 a-g maycomprise, for example, one or more passive inductive, Radio FrequencyIDentification (RFID), Near-Field-Communication (NFC), processing, powerstorage, and/or memory storage devices. In some embodiments, theelectronic devices 116 a-g may store, process, receive, and/or transmitvarious data elements such as to track geographical movement of the BFSvial package 102 and/or to verify or confirm that a particular BFS vial104 a-g should be utilized for administration to a particular recipient.

In some embodiments for example, in the case that a user (whether ahealthcare worker, a patient who is self-injecting or a friend or familymember injecting a patient) is about to inject a fluid agent utilizingthe first BFS vial 104 a that comprises a first electronic device 116 asuch as an NFC chip, the user may first open an appropriate app onhis/her mobile device (not shown) and tap (or bring into proximity) thefirst BFS vial 104 a and/or the first electronic device 116 a to themobile device to initiate communications therebetween. This may allow,in some embodiments, the app to verify the injection by verifying and/orauthenticating one or more of the following: (i) that the fluid is thecorrect fluid agent the patient is supposed to be receiving (e.g., basedon a comparison of fluid data stored by the first electronic device 116a and patient information stored in a separate memory device, e.g., ofthe user's mobile device); (ii) that the injection is being administeredwithin an appropriate window of time (e.g., by comparing a current timeand/or date to a time and/or date stored and/or referenced by data ofthe first electronic device 116 a); (iii) that the first BFS vial 104 aand/or fluid therein has not been compromised and/or is not expired.According to some embodiments, any of the foregoing may be verifiedbased on records of the patient stored in the app on the mobile deviceand/or accessible to the app via the internet or a cloud-based systemand/or data stored in the first electronic device 116 a. In someembodiments, in the case that the required (or desired) verificationsare processed successfully, the user may be authorized to perform theinjection (e.g., an approval indicator may be output to the user via ascreen of the app). The user may be motivated to only inject uponreceiving the approval via the app because the user may only receiverewards via the app if he/she performs approved injections. In someembodiments, the user may also be requested to upload a photo of thefirst BFS vial 104 a and/or the injection site (not shown) after theinjection (e.g., to finalize qualification for a reward and/or toqualify for an additional reward). According to some embodiments, areward may be provided to the user via the user's mobile device, e.g.,in response to receiving data descriptive of the administration of thefluid and/or the use of the first BFS vial 104 a.

In some embodiments, fewer or more components 104 a-g, 104 a-1, 104 a-2,106 a-g, 108 a, 108 a-1, 108 a-2, 110 a-g, 112 a, 112 a-1, 114 a-g, 116a-g and/or various configurations of the depicted components 104 a-g,104 a-1, 104 a-2, 106 a-g, 108 a, 108 a-1, 108 a-2, 110 a-g, 112 a, 112a-1, 114 a-g, 116 a-g may be included in the BFS vial package 102without deviating from the scope of embodiments described herein. Insome embodiments, the components 104 a-g, 104 a-1, 104 a-2, 106 a-g, 108a, 108 a-1, 108 a-2, 110 a-g, 112 a, 112 a-1, 114 a-g, 116 a-g may besimilar in configuration and/or functionality to similarly named and/ornumbered components as described herein. In some embodiments, the BFSvial package 102 (and/or portion and/or component 104 a-g, 104 a-1, 104a-2, 106 a-g, 108 a, 108 a-1, 108 a-2, 110 a-g, 112 a, 112 a-1, 114 a-g,116 a-g thereof) may be utilized in accordance with the method 900 ofFIG. 9 herein, and/or portions thereof.

Turning now to FIG. 2 , a front view of a fluid delivery manifold 222according to some embodiments is shown. The fluid delivery manifold 222may, for example, be configured to mate with a BFS vial package (notshown; such as the BFS vial package 102 of FIG. 1 herein). In someembodiments, the fluid delivery manifold 222 may comprise a plurality offluid delivery hubs 224 a-g, each, e.g., configured to mate with a BFSvial (not shown; such as the BFS vials 104 a-g of FIG. 1 herein).According to some embodiments, one or more of the fluid delivery hubs224 a-g, such as a first one of the fluid delivery hubs 224 a, maycomprise and/or define a first or proximate end 224 a-1 and a second ordistal end 224 a-2. In some embodiments, the first fluid delivery hub224 a may comprise and/or define a first interior volume 224 a-3comprising one or more internal features such as a first or proximateradial channel 224 a-4 and/or a second or distal radial channel 224 a-5.According to some embodiments, the fluid delivery hubs 224 a-g maycomprise hub bodies 226 a-g, e.g., a first hub body 226 a of the firstfluid delivery hub 224 a being disposed between the first and secondends 224 a-1, 224 a-2 thereof. In some embodiments, the hub bodies 226a-g may be substantially cylindrical.

According to some embodiments, the hub bodies 226 a-g may compriseand/or define seats 228 a-g. As depicted in FIG. 2 , for example, thefirst hub body 226 a may comprise a first seat 228 a disposed or formedon an upper surface at the distal end 224 a-2 of the first hub body 226a. In some embodiments, the first seat 228 a may be in communicationwith the first interior volume 224 a-3 via a bore 228 a-1 disposedtherebetween. The bore 228 a-1 may, for example, allow for passage of anadministration member (not shown) coupled to provide fluid (e.g., towardthe distal end 224 a-2) from a BFS vial (not shown in FIG. 2 ) coupledand/or disposed in the first interior volume 224 a-3. According to someembodiments, the seats 228 a-g may be sized and/or configured to accept,couple to, and/or mater with a seal, washer, stopper, and/or otherelement (not shown) disposed therein.

In some embodiments, the hub bodies 226 a-g may be joined together toadjacent hub bodies 226 a-g via one or more hub connectors 230. The hubconnectors 230 and the hub bodies 226 a-g may be formed together as aresult of a BFS manufacturing process, for example, such as by beingextruded from the same plastic and/or polymer material acted upon by asingle BFS mold or die. According to some embodiments, the hubconnectors 230 may be configured to be easily removed from the hubbodies 226 a-g such as by incorporating perforations, stress points,and/or break points that are designed to shear, tear, or sever inresponse to certain applied forces. The first fluid delivery hub 224 amay be separated from an adjacent second fluid delivery hub 224 b, forexample, in response to a rotational or twisting force being applied tothe joint or juncture where a hub connector 230 is coupled to the firsthub body 226 a (and/or a second hub body 226 b). In some embodiments, adesigned stress or break point may be disposed at the juncture with thehub bodies 226 a-g, in the middle of a length of the hub connectors 230,or as is or becomes desirable and/or practicable. In such a manner, forexample, the fluid delivery manifold 222 may be quickly and easilymanufactured as a single part while allowing the individual fluiddelivery hubs 224 a-g to be selectively removed with minimal effort, asis known in the plastic manufacturing arts.

According to some embodiments, fewer or more components 224 a-g, 224a-1, 224 a-2, 224 a-3, 224 a-4, 224 a-5, 226 a-g, 228 a-g, 228 a-1, 230and/or various configurations of the depicted components 224 a-g, 224a-1, 224 a-2, 224 a-3, 224 a-4, 224 a-5, 226 a-g, 228 a-g, 228 a-1, 230may be included in the fluid delivery manifold 222 without deviatingfrom the scope of embodiments described herein. In some embodiments, thecomponents 224 a-g, 224 a-1, 224 a-2, 224 a-3, 224 a-4, 224 a-5, 226a-g, 228 a-g, 228 a-1, 230 may be similar in configuration and/orfunctionality to similarly named and/or numbered components as describedherein. In some embodiments, the fluid delivery manifold 222 (and/orportion and/or component 224 a-g, 224 a-1, 224 a-2, 224 a-3, 224 a-4,224 a-5, 226 a-g, 228 a-g, 228 a-1, 230 thereof) may be utilized inaccordance with the method 900 of FIG. 9 herein, and/or portionsthereof.

Turning now to FIG. 3 , a front view of a safety cap manifold 342according to some embodiments is shown. In some embodiments, the safetycap manifold 342 may be configured to mate with a fluid deliverymanifold (not shown) such as the fluid delivery manifold 222 of FIG. 2herein. The safety cap manifold 342 may, for example, comprise aplurality of safety caps 344 a-g each being configured to mate with arespective fluid delivery hub (not shown) such as the fluid deliveryhubs 224 a-g of FIG. 2 herein. In some embodiments, one or more of thesafety caps 344 a-g, such as a first one of the safety caps 344 a, maycomprise and/or define a first or proximate end 344 a-1 and a second ordistal end 344 a-2. In some embodiments, the first safety cap 344 a maycomprise and/or define a first lower void 344 a-3. According to someembodiments, the safety caps 344 a-g may comprise safety cap bodies 346a-g, e.g., a first safety cap body 346 a of the first safety cap 344 abeing disposed between the first and second ends 344 a-1, 344 a-2thereof. In some embodiments, the safety cap bodies 346 a-g may besubstantially cylindrical.

According to some embodiments, the safety cap bodies 346 a-g maycomprise and/or define upper voids 348 a-g. As depicted in FIG. 3 , forexample, the first safety cap body 346 a may comprise a first upper void348 a disposed, formed, and/or open at (or closed at) the distal end 344a-2 of the first safety cap body 346 a. In some embodiments, the firstupper void 348 a may be in communication with the first lower void 344a-3 via a passage 348 a-1 disposed therebetween. The passage 348 a-1may, for example, allow for passage of an administration member (notshown) housed and/or retained by a fluid delivery hub (not shown)disposed and/or coupled within the first lower void 344 a-3.

In some embodiments, the safety cap bodies 346 a-g may be joinedtogether to adjacent safety cap bodies 346 a-g via one or more capconnectors 350. The cap connectors 350 and the safety cap bodies 346 a-gmay be formed together as a result of a BFS (or other) manufacturingprocess, for example, such as by being extruded and/or injected from thesame plastic and/or polymer material acted upon by a single BFS (orother) mold or die. According to some embodiments, the cap connectors350 may be configured to be easily removed from the safety cap bodies346 a-g such as by incorporating perforations, stress points, and/orbreak points that are designed to shear, tear, or sever in response tocertain applied forces. The first safety cap 344 a may be separated froman adjacent second safety cap 344 b, for example, in response to arotational or twisting force being applied to the joint or juncturewhere a cap connector 350 is coupled to the first safety cap body 346 a(and/or a second safety cap body 346 b). In some embodiments, a designedstress or break point may be disposed at the juncture with the safetycap bodies 346 a-g, in the middle of a length of the cap connectors 350,or as is or becomes desirable and/or practicable. In such a manner, forexample, the safety cap manifold 342 may be quickly and easilymanufactured as a single part while allowing the individual safety caps344 a-g to be selectively removed with minimal effort, as is known inthe plastic manufacturing arts.

According to some embodiments, fewer or more components 344 a-g, 344a-1, 344 a-2, 344 a-3, 346 a-g, 348 a-g, 348 a-1, 350 and/or variousconfigurations of the depicted components 344 a-g, 344 a-1, 344 a-2, 344a-3, 346 a-g, 348 a-g, 348 a-1, 350 may be included in the safety capmanifold 342 without deviating from the scope of embodiments describedherein. In some embodiments, the components 344 a-g, 344 a-1, 344 a-2,344 a-3, 346 a-g, 348 a-g, 348 a-1, 350 may be similar in configurationand/or functionality to similarly named and/or numbered components asdescribed herein. In some embodiments, the safety cap manifold 342(and/or portion and/or component 344 a-g, 344 a-1, 344 a-2, 344 a-3, 346a-g, 348 a-g, 348 a-1, 350 thereof) may be utilized in accordance withthe methods 900 of FIG. 9 herein, and/or portions thereof.

Referring now to FIG. 4 , a front view of a safety cap manifold 442according to some embodiments is shown. In some embodiments, the safetycap manifold 442 may be configured to mate with a fluid deliverymanifold (not shown) such as the fluid delivery manifold 222 of FIG. 2herein. The safety cap manifold 442 may, for example, comprise aplurality of safety caps 444 a-g each being configured to mate with arespective fluid delivery hub (not shown) such as the fluid deliveryhubs 224 a-g of FIG. 2 herein. In some embodiments, one or more of thesafety caps 444 a-g, such as a first one of the safety caps 444 a, maycomprise and/or define a first or proximate end 444 a-1 and a second ordistal end 444 a-2. In some embodiments, the first safety cap 444 a maycomprise and/or define a first lower void 444 a-3 (e.g., having a firstdiameter) and/or a first upper void 444 a-4 (e.g., having a seconddiameter) in communication therewith. According to some embodiments, thesafety caps 444 a-g may comprise safety cap bodies 446 a-g, e.g., afirst safety cap body 446 a of the first safety cap 444 a being disposedbetween the first and second ends 444 a-1, 444 a-2 thereof. In someembodiments, the safety cap bodies 446 a-g may be conically shapedand/or may comprise a plurality of shaped portions.

As depicted in FIG. 4 for example, the first safety cap body 446 a maycomprise a lower body portion 446 a-1 that is cylindrically-shaped witha first outside diameter and an upper body portion 446 a-2 that iscylindrically-shaped with a second outside diameter that is smaller thatthe first outside diameter. According to some embodiments, a smoothtransition of the outside surface of the first safety cap body 446 abetween the first and second outside diameters may define a tapered bodyportion 446 a-3 between the lower body portion 446 a-1 and the upperbody portion 446 a-1. In some embodiments, the upper body portion 446a-2 may be frustoconically-shaped and/or may define therein the uppervoid 444 a-4. The upper void 444 a-4 and/or the upper body portion 446a-2 may, for example, allow for passage of an administration member (notshown) housed and/or retained by a fluid delivery hub (not shown)disposed and/or coupled within the first lower void 444 a-3.

According to some embodiments, the first safety cap body 446 a maycomprise and/or define an exterior flange 446 a-4. The exterior flange446 a-4 may, for example, be formed and/or defined by the intersectionof the upper body portion 446 a-2 and the lower body portion 446 a-1(and/or the tapered body portion 446 a-3), e.g., having a radial depthbased on the difference between the first and second outside diametersthereof. In some embodiments, the exterior flange 446 a-4 and/or thetapered body portion 446 a-3 may be utilized to apply axial forces onthe first safety cap 444 a, e.g., to effectuate activation of a fluiddelivery system (not shown) as described herein.

In some embodiments, the safety cap bodies 446 a-g may be joinedtogether to adjacent safety cap bodies 446 a-g via one or more capconnectors 450. The cap connectors 450 and the safety cap bodies 446 a-gmay be formed together as a result of a BFS (or other) manufacturingprocess, for example, such as by being extruded and/or injected from thesame plastic and/or polymer material acted upon by a single BFS (orother) mold or die. According to some embodiments, the cap connectors450 may be configured to be easily removed from the safety cap bodies446 a-g such as by incorporating perforations, stress points, and/orbreak points that are designed to shear, tear, or sever in response tocertain applied forces. The first safety cap 444 a may be separated froman adjacent second safety cap 444 b, for example, in response to arotational or twisting force being applied to the joint or juncturewhere a cap connector 450 is coupled to the first safety cap body 446 a(and/or a second safety cap body 446 b). In some embodiments, a designedstress or break point may be disposed at the juncture with the safetycap bodies 446 a-g, in the middle of a length of the cap connectors 450,or as is or becomes desirable and/or practicable. In such a manner, forexample, the safety cap manifold 442 may be quickly and easilymanufactured as a single part while allowing the individual safety caps444 a-g to be selectively removed with minimal effort, as is known inthe plastic manufacturing arts.

According to some embodiments, fewer or more components 444 a-g, 444a-1, 444 a-2, 444 a-3, 444 a-4, 446 a-g, 446 a-1, 446 a-2, 446 a-3, 446a-4, 450 and/or various configurations of the depicted components 444a-g, 444 a-1, 444 a-2, 444 a-3, 444 a-4, 446 a-g, 446 a-1, 446 a-2, 446a-3, 446 a-4, 450 may be included in the safety cap manifold 442 withoutdeviating from the scope of embodiments described herein. In someembodiments, the components 444 a-g, 444 a-1, 444 a-2, 444 a-3, 444 a-4,446 a-g, 446 a-1, 446 a-2, 446 a-3, 446 a-4, 450 may be similar inconfiguration and/or functionality to similarly named and/or numberedcomponents as described herein. In some embodiments, the safety capmanifold 442 (and/or portion and/or component 444 a-g, 444 a-1, 444 a-2,444 a-3, 444 a-4, 446 a-g, 446 a-1, 446 a-2, 446 a-3, 446 a-4, 450thereof) may be utilized in accordance with the methods 900 of FIG. 9herein, and/or portions thereof.

Turning now to FIG. 5A and FIG. 5B, front and cross-sectional views of afluid delivery manifold system 500 according to some embodiments areshown. The fluid delivery manifold system 500 may comprise, for example,a BFS vial package 502 comprising a plurality if individual BFS vials504 a-g. Features of the BFS vials 504 a-g are described inrepresentative detail by referring to a first one of the BFS vials 504 a(e.g., the left-most BFS vial 504 a-g of the BFS vial package 502).According to some embodiments, the first BFS vial 504 a may comprise afirst or proximate end 504 a-1 and a second or distal end 504 a-2between which is disposed a first vial body 506 a. In some embodiments,each BFS vials 504 a-g may comprise a vial body 506 a-g that may becoupled to any adjacent vial body 506 a-g in the BFS vial package 502and/or may be coupled to and/or define various features. With referenceto the first BFS vial 504 a, for example, the first vial body 506 a maycomprise, define, and/or be coupled to a first vial neck 508 a having afirst or distal radial flange 508 a-1 and/or a second or proximateradial flange 508 a-2 formed and/or coupled thereto.

According to some embodiments, each BFS vial 504 a-g may comprise afluid reservoir 510 a-g in communication with a respective fluid passage512 a-g (e.g., a first fluid passage 512 a of the first BFS vial 504 abeing disposed in (or formed by) the first vial neck 508 a). Withreference to the first BFS vial 504 a, for example, fluid may be storedin (e.g., injected into during an aseptic BFS manufacturing process) afirst fluid reservoir 510 a and/or the first fluid passage 512 a an maybe prevented from existing the first BFS vial 504 a by a first fluidseal 512 a-1 disposed at a distal end of the fluid passage 512 a. Insome embodiments, the BFS vials 504 a-g may comprise grip portions 514a-g and/or electronic devices 516 a-g (e.g., embedded and/or formedwithin the BFS vials 504 a-g).

In some embodiments, the fluid delivery manifold system 500 may comprisea fluid delivery manifold 522 coupled to the BFS vial package 502. Thefluid delivery manifold 522 may comprise, for example, a plurality offluid delivery hubs 524 a-g, each fluid delivery hub 524 a-g beingcoupled to a respective one of the BFS vials 504 a-g. Features of thefluid delivery hubs 524 a-g are described in representative detail byreferring to a first one of the fluid delivery hubs 524 a (e.g., theleft-most fluid delivery hub 524 a-g of the fluid delivery manifold522). The first fluid delivery hub 524 a may comprise, according to someembodiments, a first or proximate end 524 a-1 and a second or distal end524 a-2 and/or may comprise and/or define a first interior volume 524a-3. In some embodiments, the first interior volume 524 a-3 may compriseone or more internal mating features such as a first or proximate radialchannel 524 a-4 and/or a second or distal radial channel 524 a-5.According to some embodiments, the fluid delivery hubs 524 a-g maycomprise hub bodies 526 a-g, e.g., a first hub body 526 a of the firstfluid delivery hub 524 a being disposed between the first and secondends 524 a-1, 524 a-2 thereof. In some embodiments, the hub bodies 526a-g may be substantially cylindrical.

As shown in the cross-section of FIG. 5B, the first vial neck 508 a maybe inserted into the first interior volume 524 a-3 by an amount thataligns first radial flange 508 a-1 with the proximate radial channel 524a-4. In some embodiments, engagement and/or insertion of the first vialneck 508 a into the first interior volume 524 a-3 may cause the firstvial neck 508 a of the first BFS vial 504 a (and/or the first radialflange 508 a-1 thereof) to compress radially inward and/or may cause thefirst hub body 526 a to expand radially outward (e.g., elastically), toallow continued advancement of the first BFS vial 504 a into the firstinterior volume 524 a-3, e.g., in accordance with a tight fit and/orinterference fit engagement. According to some embodiments, the radialpressure exerted by forcing the first vial neck 508 a of the first BFSvial 504 a into the first interior volume 524 a-3 may impart a radialspring effect to the first radial flange 508 a-1 (or a portion thereof)such that when axial advancement aligns the first radial flange 508 a-1with the corresponding proximate radial channel 524 a-4, the firstradial flange 508 a-1 (or a portion thereof) may spring radially outwardand into the corresponding proximate radial channel 524 a-4, therebyreducing and/or removing the radial pressure exerted thereon by thedifference between an diameter of the first interior volume 524 a-3 andan outside diameter and/or radial extents of the first radial flange 508a-1. In such a manner, for example, each BFS vial 504 a-g may be snappedinto each respective fluid delivery hub 524 a-g.

According to some embodiments, the hub bodies 526 a-g may compriseand/or define seats 528 a-g. As depicted in FIG. 5B, for example, thefirst hub body 526 a may comprise a first seat 528 a disposed or formedon an upper surface at the distal end 524 a-2 of the first hub body 526a. In some embodiments, the first seat 528 a may be in communicationwith the first interior volume 524 a-3 via a bore 528 a-1 disposedtherebetween. In some embodiments, the hub bodies 526 a-g may be joinedtogether to adjacent hub bodies 526 a-g via one or more hub connectors530. In such a manner, for example, the fluid delivery manifold 522 maybe mated with or coupled to the BFS vial package 502 (e.g., as part of amanufacturing assembly process).

In some embodiments, the fluid delivery manifold system 500 may comprisea safety cap manifold 542 coupled to the fluid delivery manifold 522.The safety cap manifold 542 may comprise, for example, a plurality ofsafety caps 544 a-g, each safety cap 544 a-g being coupled to arespective one of the fluid delivery hubs 524 a-g. Features of thesafety caps 544 a-g are described in representative detail by referringto a first one of the safety caps 544 a (e.g., the left-most safety cap544 a-g of the safety cap manifold 542). The first safety cap 544 a maycomprise, according to some embodiments, a first or proximate end 544a-1 and a second or distal end 544 a-2 and/or may comprise and/or definea lower void 544 a-3, e.g., open at the proximate end 544 a-1. In someembodiments, the lower void 544 a-3 may comprise one or more internalmating features (not shown) such as to mate to corresponding features(also not shown) on an outside surface of the first fluid delivery hub524 a to which the first safety cap 544 a is coupled.

According to some embodiments, the first safety cap 544 a may comprise afirst cap body 546 a disposed between the first and second ends 544 a-1,544 a-2 thereof. In some embodiments, the first cap body 546 a may besubstantially cylindrical. In some embodiments, the safety caps 544 a-gmay comprise and/or define upper voids 548 a-g. The first safety cap 544a may comprise a first upper void 548 a open at the distal end 544 a-2,for example, and/or in communication with the first lower void 544 a-3,e.g., via a first passage 548 a-1. In some embodiments, the cap bodies546 a-g may be joined together to adjacent cap bodies 546 a-g via one ormore cap connectors 550. In such a manner, for example, the safety capmanifold 542 may be mated with or coupled to the fluid delivery manifold522 (e.g., as part of a manufacturing assembly process).

In some embodiments, the mated safety caps 544 a-g and fluid deliveryhubs 524 a-g may house and/or retain needles or administration members560 a-g (e.g., for at least one of subcutaneous, intramuscular,intradermal, and intravenous injection) and/or seals 570 a-g. As shownwith respect to the first BFS vial 504 a, the first fluid delivery hub524 a, and the first safety cap 544 a coupling, for example, a firstadministration member 560 a may extend from within the interior volume524 a-3 (e.g., proximate to the first fluid seal 512 a-1) of the firstfluid delivery hub 524 a, through the bore 528 a-1 and the first seat528 a and into the lower void 544 a-3 of the first safety cap 544 a.According to some embodiments, within the lower void 544 a-3 of thefirst safety cap 544 a the first administration member 560 a may passthrough and/or be coupled to a first seal 570 (e.g., an annular rubberseal) and pass through the passage 548 a-1 of the first safety cap 544 aand into the first upper void 548 a thereof. In some embodiments, theupper void 548 a may be closed at the distal end 544 a-2, e.g., toprevent accidental access to the first administration member 560 a.According to some embodiments, the axial length of the first safety cap544 a and/or the axial depth or extent of the first upper void 548 a maybe substantially longer than the length of the first administrationmember 560 a exposed in the first upper void 548 a and/or the upper void548 a may otherwise not need to be closed at the distal end 544 a-2.

According to some embodiments, any coupled set of BFS vials 504 a-g,fluid delivery hubs 524 a-g, and safety caps 544 a-g may be configuredto be easily removed from the fluid delivery manifold system 500 such asby incorporating perforations, stress points, and/or break points thatare designed to shear, tear, or sever in response to certain appliedforces. Rotational or twisting force applied to the coupled first BFSvial 504 a, first fluid delivery hub 524 a, and first safety cap 544 amay, for example, generate stresses (i) along a coupling between thefirst vial body 506 a and an adjacent second vial body 506 b, (ii)within the hub connector 530 connecting the first fluid delivery hub 524a and an adjacent second delivery hub 524 b, and/or (iii) within the capconnector 550 connecting the first safety cap 544 a and an adjacentsecond safety cap 544 b. Reduced cross-sectional area at one or more ofthese various connections may be designed to fail in response toexperiencing such stresses, thereby permitting a single-dose BFS vial504 a-g, fluid delivery hub 542 a-g, and safety cap 544 a-g unit to beeasily and selectively removed from the fluid delivery manifold system500.

While a certain style of safety cap 544 a-g is depicted in FIG. 5A andFIG. 5B, it should be understood that different styles and/orconfigurations of safety caps 544 a-g (e.g., as described herein) may beutilized without deviating from the scope of some embodiments. Accordingto some embodiments, the fluid delivery manifold system 500 may bedepicted in FIG. 5A and FIG. 5B in a first, assembled, and/ornon-activated state. As depicted, for example, the administrationmembers 560 a-g have not yet been engaged to puncture the BFS vials 504a-g to permit release and/or administration of the fluid stored in thefluid reservoirs 510 a-g. In some embodiments, an axial compressiveforce may be applied to the safety caps 544 a-g and/or the fluiddelivery hubs 524 a-g in one direction and the grip portions 514 a-g inan opposite direction, to urge the BFS vials 504 a-g further into thefluid delivery hubs 524 a-g and cause the administration members 560 a-gto pierce the respective BFS vials 504 a-g. In some embodiments, such anactivation may be accomplished for single BFS vial 504 a-g at a time oractivation may be effectuated for multiple BFS vials 504 a-g at onetime, e.g., as permitted by the structural configurations, alignment,and engagement of the BFS vial package 502, the fluid delivery manifold522, and the safety cap manifold 542.

In some embodiments, fewer or more components 502, 504 a-g, 504 a-1, 504a-2, 506 a-g, 508 a, 508 a-1, 508 a-2, 510 a-g, 512 a-g, 514 a-g, 516a-g, 522, 524 a-g, 524 a-1, 524 a-2, 524 a-3, 524 a-4, 524 a-5, 526 a-g,528 a-g, 528 a-1, 530, 542, 544 a-g, 544 a-1, 544 a-2, 544 a-3, 546 a,548 a-g, 548 a-1, 550, 560 a-g, 570 a-g and/or various configurations ofthe depicted components 502, 504 a-g, 504 a-1, 504 a-2, 506 a-g, 508 a,508 a-1, 508 a-2, 510 a-g, 512 a-g, 514 a-g, 516 a-g, 522, 524 a-g, 524a-1, 524 a-2, 524 a-3, 524 a-4, 524 a-5, 526 a-g, 528 a-g, 528 a-1, 530,542, 544 a-g, 544 a-1, 544 a-2, 544 a-3, 546 a, 548 a-g, 548 a-1, 550,560 a-g, 570 a-g may be included in the fluid delivery manifold system500 without deviating from the scope of embodiments described herein. Insome embodiments, the components 502, 504 a-g, 504 a-1, 504 a-2, 506a-g, 508 a, 508 a-1, 508 a-2, 510 a-g, 512 a-g, 514 a-g, 516 a-g, 522,524 a-g, 524 a-1, 524 a-2, 524 a-3, 524 a-4, 524 a-5, 526 a-g, 528 a-g,528 a-1, 530, 542, 544 a-g, 544 a-1, 544 a-2, 544 a-3, 546 a, 548 a-g,548 a-1, 550, 560 a-g, 570 a-g may be similar in configuration and/orfunctionality to similarly named and/or numbered components as describedherein. In some embodiments, the fluid delivery manifold system 500(and/or portion and/or component 502, 504 a-g, 504 a-1, 504 a-2, 506a-g, 508 a, 508 a-1, 508 a-2, 510 a-g, 512 a-g, 514 a-g, 516 a-g, 522,524 a-g, 524 a-1, 524 a-2, 524 a-3, 524 a-4, 524 a-5, 526 a-g, 528 a-g,528 a-1, 530, 542, 544 a-g, 544 a-1, 544 a-2, 544 a-3, 546 a, 548 a-g,548 a-1, 550, 560 a-g, 570 a-g thereof) may be utilized in accordancewith the method 900 of FIG. 9 herein, and/or portions thereof.

Turning now to FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, FIG. 6E, FIG. 6F,FIG. 6G, and FIG. 6H, top-front perspective, top, bottom, left, right,front, back, and cross-sectional views of a fluid delivery hub 624according to some embodiments are shown. The fluid delivery hub 624 maycomprise, for example, a first or proximate end 624-1 and a second ordistal end 624-2 and/or may define an interior volume 624-3 (e.g., openat the proximate end 624-1). In some embodiments, the interior volume624-3 may comprise and/or define one or more mating features (e.g., onan inside surface of the fluid delivery hub 624) such as a first orproximate radial channel 624-4 and/or a second or distal radial channel624-5. According to some embodiments, the channels 624-4, 624-5 may bebeveled and/or rounded, as shown, to facilitate entry and exit ofcorresponding mating flanges (not shown) thereof. In some embodiments, alower edge of one or more of the channels 624-4, 624-5 may comprise aright-angle or other angular profile (not shown) such that acorresponding mating feature may readily enter the channel 624-4, 624-5from the proximate end 624-1 but may be impeded from exiting the channel624-4, 624-5 (e.g., from backing out) toward the proximate end 624-1. Insuch a manner, for example, a BFS vial (not shown) with a correspondingmating feature(s) may be easily inserted into the interior volume 624-3but may be locked therein once engaged, e.g., to prevent attempted reuseof the fluid delivery hub 624.

According to some embodiments, the interior volume 624-3 may be definedby a hub body 626 such as a cylindrical shape as-depicted. In someembodiments, the fluid delivery hub 624 (and/or the hub body 626thereof) may comprise and/or define a seat 628. The seat 628 maycomprise, for example, a depression, indent, and/or counter-sink featuredisposed on a top surface of the hub body 626 at the distal end 624-2.In some embodiments, the seat 628 may comprise a void or volume that isin communication with the interior volume 624-3 via a bore 628-1.According to some embodiments, the fluid delivery hub 624 (and/or thehub body 626 thereof) may comprise a hub connector 630 that may, forexample, comprise an element molded and/or coupled to the hub body 626and operable to be coupled to an adjacent fluid delivery hub (notshown). In some embodiments, the hub connector 630 may comprise aportion of a connective element that connected the hub body 626 to andadjacent hub body and then was selectively severed to remove the fluiddelivery hub 624, e.g., from a fluid delivery manifold (not shown) suchas the fluid delivery manifolds 222, 522, of FIG. 2 , FIG. 5A, and/orFIG. 5B herein.

In some embodiments, fewer or more components 624-1, 624-2, 624-3,624-4, 624-5, 626, 628, 628-1, 630 and/or various configurations of thedepicted components 624-1, 624-2, 624-3, 624-4, 624-5, 626, 628, 628-1,630 may be included in the fluid delivery hub 624 without deviating fromthe scope of embodiments described herein. In some embodiments, thecomponents 624-1, 624-2, 624-3, 624-4, 624-5, 626, 628, 628-1, 630 maybe similar in configuration and/or functionality to similarly namedand/or numbered components as described herein. In some embodiments, thefluid delivery hub 624 (and/or portion and/or component 624-1, 624-2,624-3, 624-4, 624-5, 626, 628, 628-1, 630 thereof) may be utilized inaccordance with the method 900 of FIG. 9 herein, and/or portionsthereof.

Turning now to FIG. 7A and FIG. 7B, cross-sectional views of a fluiddelivery manifold system 700 according to some embodiments are shown. Insome embodiments, the fluid delivery manifold system 700 may be depictedin various states of activation in FIG. 7A and FIG. 7B. In FIG. 7A, forexample, the fluid delivery manifold system 700 may be depicted in afirst or unengaged state while in FIG. 7B the fluid delivery manifoldsystem 700 may be depicted in a second or engaged state. According tosome embodiments, a user (not shown) may progress the fluid deliverymanifold system 700 from the first state to the second state byselective application of axial force that ultimately causes a fluid tobe delivered to a recipient (not shown; e.g., a therapeutic and/ormedical fluid to be delivered to a patient).

According to some embodiments, the fluid delivery manifold system 700may comprise a BFS vial neck 708 having a first or distal exteriorradial flange 708-1 and a second or proximate exterior radial flange708-2. In some embodiments, a fluid (not explicitly shown) may reside inand/or travel through a fluid passage 712 within the BFS vial neck 708and/or may be contained by a fluid seal 712-1. The fluid seal 712-1 maybe integral to the BFS vial neck 708 such as by being formed during aBFS manufacturing process together with the BFS vial neck 708 or maycomprise a separate element coupled to seal the BFS vial neck 708 andattendant fluid passage 712 thereof.

In some embodiments, the fluid delivery manifold system 700 may comprisea fluid delivery hub 724 coupled to the BFS vial neck 708. The BFS vialneck 708 may, for example, be at least partially inserted into aninterior volume 724-3 defined by the fluid delivery hub 724, e.g., asshown in FIG. 7A. According to some embodiments, the BFS vial neck 708may have been inserted to a first position within the interior volume724-3 as shown in FIG. 7A, such that the first radial flange 708-1engages with and/or becomes seated in a first or proximate radialchannel 724-4 disposed on an inside surface of the interior volume724-3. As depicted in FIG. 7B, continued advancement of the BFS vialneck 708 into the interior volume 724-3 may cause the first radialflange 708-1 to disengage with and/or move out of the first radialchannel 724-4 and travel along the inside surface of the interior volume724-3 until it becomes engaged with and/or seated in a second or distalradial channel 724-5 (as shown in FIG. 7B). Upon achieving such a secondand/or additional level of insertion into the interior volume 724-3, insome embodiments the second radial flange 708-2 may become engaged withand/or seated in the first radial channel 724-4 (also as shown in FIG.7B). In such a manner, for example, at the first state shown in FIG. 7Athe BFS vial neck 708 may be secured to the fluid delivery hub 724 at afirst position (e.g., via engagement of the first radial flange 708-1with the first radial channel 724-4; e.g., a transport, assembly, and/orpre-engagement position) while at the second state shown in FIG. 7B theBFS vial neck 708 may be secured to the fluid delivery hub 724 at asecond position (e.g., via engagement of the first radial flange 708-1with the second radial channel 724-5 and engagement of the second radialflange 708-2 with the first radial channel 724-4; e.g., an engagementposition). In some embodiments, the interior volume 724-3 (and/or thechannels 724-4, 724-5 thereof) may be formed and/or defined by a hubbody 726. According to some embodiments, the hub body 726 may compriseand/or define a seat 728 disposed opposite to the interior volume 724-3and/or a bore 728-1 extending between the seat 728 and the interiorvolume 724-3.

In some embodiments, the fluid delivery manifold system 700 may comprisea safety cap 744 defining a lower void 744-3 into which the hub body 726is at least partially inserted and/or disposed (e.g., as shown in FIG.7A). The lower void 744-3 may comprise an inside diameter equivalent to(or slightly smaller than) an outside diameter of the hub body 726, forexample, such as permitting for a desired fit therebetween. According tosome embodiments, the lower void 744-3 may be defined by a cap body 746that may, for example, be cylindrically-shaped. In some embodiments, thesafety cap 744 (and/or cap body 746 thereof) may comprise and/or definean upper void 748 in communication with the lower void 744-3 via apassage 748-1.

According to some embodiments, the fluid delivery manifold system 700may comprise an administration member 760 (such as a needle or tube;e.g., a needle having a length in the ranges of (i) 0.5 mm to 4 mm, (ii)4 mm to 15 mm, or (iii) 15 mm to 30 mm) having a first or proximate end760-1 and a second or distal end 760-2. In some embodiments, theadministration member 760 may be hollow and/or may otherwise define afluid channel 760-3 extending from the first end 760-1 to the second end760-3. In some embodiments, the administration member 760 may passthrough and/or be coupled to a seal 770 disposed in the lower void744-3. The seal 770 may comprise, for example, an annular rubber orthermoplastic element that may be deformable or pliable. According tosome embodiments, either or both of the first end 760-1 and the secondend 760-2 of the administration member 760 may comprise a tip, point,prong, blade, and/or other feature and/or configuration, such as topierce the fluid seal 712-1 (e.g., in the case of the fires end 760-1)or pierce an administration surface (such as skin; not shown; e.g., inthe case of the second end 760-2).

In some embodiments, and as depicted in FIG. 7A, at the first ordisengaged state of the fluid delivery manifold system 700 the first end760-1 of the administration member 760 may be disposed in the interiorvolume 724-3 of the fluid delivery hub 724 and the second end 760-2 ofthe administration member 760 may be disposed in the upper void 748 ofthe safety cap 744. The administration member 760 may pass through, forexample, each of the bore 728-1 (and the seat 728), the seal 770, andthe passage 748-1. According to some embodiments, axial force may beapplied to transition the fluid delivery manifold system 700 to thesecond or engaged state of FIG. 7B where the first end 760-1 of theadministration member 760 has pierced the fluid seal 712-1 and isdisposed within the fluid passage 712 of the BFS vial neck 708 and wherethe seal 770 is seated in, engaged with, and/or coupled to the seat 728.In such a manner, for example, the fluid delivery manifold system 700may be engaged to provide the fluid from the fluid passage 712, throughthe fluid channel 760-3, and into a recipient (not shown). In someembodiments, the safety cap 744 may be removed to expose theadministration member 760 and/or the second end 760-2 thereof foradministration of the fluid. According to some embodiments, axial force(downward, as-oriented in FIG. 7A and FIG. 7B) may cause the seal 770 todeform and/or compress into the seat 728. Axial force applied to thesafety cap 744 may cause the cap body 746 (and/or the ceiling of theinterior volume 724-3) to act upon the seal 770 and urge the seal 770axially downward (e.g., as depicted transitioning from FIG. 7A to FIG.7B). In some embodiments, once the seal 770 contacts the seat 728 it maybe forced therein and/or may be deformed or compressed into the seat728.

According to some embodiments, upon the seal 770 achieving a degree ofcompression and/or deformation, force may be transferred to the hub body726, causing the first radial flange 708-1 of the BFS vial neck 708 tounseat and/or disengage from the first radial channel 724-4, allowingthe fluid delivery hub 724 to progress to further envelope the BFS vialneck 708 (e.g., the BFS vial neck 708 advancing further into theinterior volume 724-3). In some embodiments, the BFS vial neck 708 maycomprise a plastic and/or polymer having a higher degree ofcompressibility than that of the fluid delivery hub 724, such that theprogression of the radial flanges 708-1, 708-2 along the inside walls ofthe interior volume 724-3 may cause a radially inward compression and/ordeformation of the flanges 708-1, 708-2. In some embodiments, suchcompression may be elastic such that upon encountering an increasedinterior diameter at the location of either of the channels 724-4, 724-5the flanges 708-1, 708-2 may spring back radially outward to seat withinthe channels 724-4, 724-5. According to some embodiments, the seal 770may be affixed and/or coupled to the administration member 760 such thataxial force applied to the seal 770 causes the administration member 760to move (e.g., as depicted in FIG. 7A and FIG. 7B).

In some embodiments, fewer or more components 708, 708-1, 708-2, 712,712-1, 724, 724-3, 724-4, 724-5, 726, 728, 728-1, 744, 744-3, 746, 748,748-1, 760, 760-1, 760-2, 760-3, 770 and/or various configurations ofthe depicted components 708, 708-1, 708-2, 712, 712-1, 724, 724-3,724-4, 724-5, 726, 728, 728-1, 744, 744-3, 746, 748, 748-1, 760, 760-1,760-2, 760-3, 770 may be included in the fluid delivery manifold system700 without deviating from the scope of embodiments described herein. Insome embodiments, the components 708, 708-1, 708-2, 712, 712-1, 724,724-3, 724-4, 724-5, 726, 728, 728-1, 744, 744-3, 746, 748, 748-1, 760,760-1, 760-2, 760-3, 770 may be similar in configuration and/orfunctionality to similarly named and/or numbered components as describedherein. In some embodiments, the fluid delivery manifold system 700(and/or portion and/or component 708, 708-1, 708-2, 712, 712-1, 724,724-3, 724-4, 724-5, 726, 728, 728-1, 744, 744-3, 746, 748, 748-1, 760,760-1, 760-2, 760-3, 770 thereof) may be utilized in accordance with themethod 900 of FIG. 9 herein, and/or portions thereof.

Referring now to FIG. 8A and FIG. 8B, cross-sectional views of a fluiddelivery manifold system 800 according to some embodiments are shown. Insome embodiments, the fluid delivery manifold system 800 may be depictedin various states of activation in FIG. 8A and FIG. 8B. In FIG. 8A, forexample, the fluid delivery manifold system 800 may be depicted in afirst or unengaged state while in FIG. 8B the fluid delivery manifoldsystem 800 may be depicted in a second or engaged state. According tosome embodiments, a user (not shown) may progress the fluid deliverymanifold system 800 from the first state to the second state byselective application of axial force that ultimately causes a fluid tobe delivered to a recipient (not shown; e.g., a therapeutic and/ormedical fluid to be delivered to a patient).

According to some embodiments, the fluid delivery manifold system 800may comprise a BFS vial neck 808 having a first or distal exteriorradial flange 808-1 and a second or proximate exterior radial flange808-2. In some embodiments, a fluid (not explicitly shown) may reside inand/or travel through a fluid passage 812 within the BFS vial neck 808and/or may be contained by a fluid seal 812-1. The fluid seal 812-1 maybe integral to the BFS vial neck 808 such as by being formed during aBFS manufacturing process together with the BFS vial neck 808 or maycomprise a separate element coupled to seal the BFS vial neck 808 andattendant fluid passage 812 thereof.

In some embodiments, the fluid delivery manifold system 800 may comprisea fluid delivery hub 824 coupled to the BFS vial neck 808. The BFS vialneck 808 may, for example, be at least partially inserted into aninterior volume 824-3 defined by the fluid delivery hub 824, e.g., asshown in FIG. 8A. According to some embodiments, the BFS vial neck 808may have been inserted to a first position within the interior volume824-3 as shown in FIG. 8A, such that the first radial flange 808-1engages with and/or becomes seated in a first or proximate radialchannel 824-4 disposed on an inside surface of the interior volume824-3. As depicted in FIG. 8B, continued advancement of the BFS vialneck 808 into the interior volume 824-3 may cause the first radialflange 808-1 to disengage with and/or move out of the first radialchannel 824-4 and travel along the inside surface of the interior volume824-3 until it becomes engaged with and/or seated in a second or distalradial channel 824-5 (as shown in FIG. 8B). Upon achieving such a secondand/or additional level of insertion into the interior volume 824-3, insome embodiments the second radial flange 808-2 may become engaged withand/or seated in the first radial channel 824-4 (also as shown in FIG.8B). In such a manner, for example, at the first state shown in FIG. 8Athe BFS vial neck 708 may be secured to the fluid delivery hub 824 at afirst position (e.g., via engagement of the first radial flange 808-1with the first radial channel 824-4; e.g., a transport, assembly, and/orpre-engagement position) while at the second state shown in FIG. 8B theBFS vial neck 808 may be secured to the fluid delivery hub 824 at asecond position (e.g., via engagement of the first radial flange 808-1with the second radial channel 824-5 and engagement of the second radialflange 808-2 with the first radial channel 824-4; e.g., an engagementposition). In some embodiments, the interior volume 824-3 (and/or thechannels 824-4, 824-5 thereof) may be formed and/or defined by a hubbody 826. According to some embodiments, the hub body 826 may compriseand/or define a seat 828 disposed opposite to the interior volume 824-3and/or a bore 828-1 extending between the seat 828 and the interiorvolume 824-3.

In some embodiments, the fluid delivery manifold system 800 may comprisea safety cap 844 defining a lower void 844-3 into which the hub body 826is at least partially inserted and/or disposed (e.g., as shown in FIG.8A) and/or an upper void 844-4. The lower void 844-3 may comprise aninside diameter equivalent to (or slightly smaller than) an outsidediameter of the hub body 826, for example, such as permitting for adesired fit therebetween. According to some embodiments, the lower void844-3 may be defined by a cap body 846 that may, for example, becomprise a lower body portion 846-1 having a first exterior diameter andan upper body portion 846-2 having a second exterior diameter. Accordingto some embodiments, in the case that the second exterior diameter issmaller than the first exterior diameter, the cap body 846 may compriseand/or define (e.g., at a transition between the lower cap body 846-1and the upper cap body 846-2) an exterior flange 846-4. In someembodiments, the upper void 844-4 may be defined within the upper bodyportion 846-2 and the lower void 844-3 may be defined within the lowerbody portion 846-1.

According to some embodiments, the fluid delivery manifold system 800may comprise an administration member 860 (such as a needle or tube)having a first or proximate end 860-1 and a second or distal end 860-2.In some embodiments, the administration member 860 may be hollow and/ormay otherwise define a fluid channel 860-3 extending from the first end860-1 to the second end 860-3. In some embodiments, the administrationmember 860 may pass through and/or be coupled to a seal 870 disposed inthe lower void 844-3. The seal 870 may comprise, for example, an annularrubber or thermoplastic element that may be deformable or pliable.According to some embodiments, either or both of the first end 860-1 andthe second end 860-2 of the administration member 860 may comprise atip, point, prong, blade, and/or other feature and/or configuration,such as to pierce the fluid seal 812-1 (e.g., in the case of the firesend 860-1) or pierce an administration surface (such as skin; not shown;e.g., in the case of the second end 860-2).

In some embodiments, and as depicted in FIG. 8A, at the first ordisengaged state of the fluid delivery manifold system 800 the first end860-1 of the administration member 860 may be disposed in the interiorvolume 824-3 of the fluid delivery hub 824 and the second end 860-2 ofthe administration member 860 may be disposed in the upper void 848 ofthe safety cap 844. The administration member 860 may pass through, forexample, each of the bore 828-1 (and the seat 828), the seal 870, andthe passage 848-1. According to some embodiments, axial force may beapplied (e.g., to the exterior flange 846-4) to transition the fluiddelivery manifold system 800 to the second or engaged state of FIG. 8Bwhere the first end 860-1 of the administration member 860 has piercedthe fluid seal 812-1 and is disposed within the fluid passage 812 of theBFS vial neck 808 and where the seal 870 is seated in, engaged with,and/or coupled to the seat 828. In such a manner, for example, the fluiddelivery manifold system 800 may be engaged to provide the fluid fromthe fluid passage 812, through the fluid channel 860-3, and into arecipient (not shown). In some embodiments, the safety cap 844 may beremoved to expose the administration member 860 and/or the second end860-2 thereof for administration of the fluid. According to someembodiments, axial force (downward, as-oriented in FIG. 8A and FIG. 8B)may cause the seal 870 to deform and/or compress into the seat 828.Axial force applied to the safety cap 844 (e.g., to the exterior flange846-4 thereof) may cause the cap body 846 (and/or the ceiling of theinterior volume 824-3) to act upon the seal 870 and urge the seal 870axially downward (e.g., as depicted transitioning from FIG. 8A to FIG.8B). In some embodiments, once the seal 870 contacts the seat 828 it maybe forced therein and/or may be deformed or compressed into the seat828.

According to some embodiments, upon the seal 870 achieving a degree ofcompression and/or deformation, force may be transferred to the hub body826, causing the first radial flange 808-1 of the BFS vial neck 808 tounseat and/or disengage from the first radial channel 824-4, allowingthe fluid delivery hub 824 to progress to further envelope the BFS vialneck 808 (e.g., the BFS vial neck 808 advancing further into theinterior volume 824-3). In some embodiments, the BFS vial neck 808 maycomprise a plastic and/or polymer having a higher degree ofcompressibility than that of the fluid delivery hub 824, such that theprogression of the radial flanges 808-1, 808-2 along the inside walls ofthe interior volume 824-3 may cause a radially inward compression and/ordeformation of the flanges 808-1, 808-2. In some embodiments, suchcompression may be elastic such that upon encountering an increasedinterior diameter at the location of either of the channels 824-4, 824-5the flanges 808-1, 808-2 may spring back radially outward to seat withinthe channels 824-4, 824-5. According to some embodiments, the seal 870may be affixed and/or coupled to the administration member 860 such thataxial force applied to the seal 870 causes the administration member 860to move (e.g., as depicted in FIG. 8A and FIG. 8B).

In some embodiments, fewer or more components 808, 808-1, 808-2, 812,812-1, 824, 824-3, 824-4, 824-5, 826, 828, 828-1, 844, 844-3, 844-4,846, 846-1, 846-2, 846-4, 860, 860-1, 860-2, 860-3, 870 and/or variousconfigurations of the depicted components 808, 808-1, 808-2, 812, 812-1,824, 824-3, 824-4, 824-5, 826, 828, 828-1, 844, 844-3, 844-4, 846,846-1, 846-2, 846-4, 860, 860-1, 860-2, 860-3, 870 may be included inthe fluid delivery manifold system 800 without deviating from the scopeof embodiments described herein. In some embodiments, the components808, 808-1, 808-2, 812, 812-1, 824, 824-3, 824-4, 824-5, 826, 828,828-1, 844, 844-3, 844-4, 846, 846-1, 846-2, 846-4, 860, 860-1, 860-2,860-3, 870 may be similar in configuration and/or functionality tosimilarly named and/or numbered components as described herein. In someembodiments, the fluid delivery manifold system 800 (and/or portionand/or component 808, 808-1, 808-2, 812, 812-1, 824, 824-3, 824-4,824-5, 826, 828, 828-1, 844, 844-3, 844-4, 846, 846-1, 846-2, 846-4,860, 860-1, 860-2, 860-3, 870 thereof) may be utilized in accordancewith the method 900 of FIG. 9 herein, and/or portions thereof.

III. Fluid Delivery Manifold Methods

FIG. 9 is a flow diagram of a method 900 according to some embodiments.The method 900 may, for example, illustrate an exemplary use of thevarious fluid delivery manifold systems and/or components thereof, asdescribed herein. In some embodiments, the method 900 may comprisemultiple related and/or consecutive processes such as actions associatedwith a first process “A” and a second process “B”. According to someembodiments, the different processes “A”, “B” may be performed bydifferent entities and/or at different times and/or locations. Theprocess diagrams and flow diagrams described herein do not necessarilyimply a fixed order to any depicted actions, steps, and/or procedures,and embodiments may generally be performed in any order that ispracticable unless otherwise and specifically noted. While the order ofactions, steps, and/or procedures described herein is generally notfixed, in some embodiments, actions, steps, and/or procedures may bespecifically performed in the order listed, depicted, and/or describedand/or may be performed in response to any previously listed, depicted,and/or described action, step, and/or procedure.

According to some embodiments, the first process “A” may comprise amanufacturing and/or assembly process. In some embodiments, the firstprocess “A” and/or the method 900 may comprise assembling a BFS vialpackage with a fluid delivery manifold, at 902. A plurality of BFS vialsconnected in a package may be mated with corresponding fluid deliveryhub members that are also interconnected, for example. According to someembodiments, the assembling may include an aligning of the respectiveBFS vials (or necks thereof) with individual fluid delivery hubcomponents and applying a first axial force to cause mating of the BFSvials and fluid delivery hubs.

In some embodiments, the method 900 may comprise coupling a plurality ofadministration members (e.g., needles, droppers, nozzles) and respectivefluid seals to the fluid delivery manifold, at 904. Each fluid deliveryhub may comprise a bore in which an administration member is inserted,for example. According to some embodiments, the method 900 may compriseassembling a safety cap manifold with the fluid delivery manifold, at906. In some embodiments, the assembling may include an aligning of therespective fluid delivery hubs with individual safety caps and applyinga second axial force to cause mating of the fluid delivery hubs and thesafety caps. According to some embodiments, a plurality ofinterconnected safety caps may be aligned, for example, and engaged withthe fluid delivery hubs of the fluid delivery manifold. According tosome embodiments, the coupling and/or mating of the safety caps with thefluid delivery hubs may cause the administration members and/or fluidseals to become encapsulated, retained, and/or restricted. In someembodiments, each administration member and each fluid seal may behoused within a respective safety cap and/or between the safety cap anda respective fluid delivery hub. In some embodiments, the assembly andcoupling actions may occur in an aseptic environment, such as part of anaseptic BFS manufacturing process that also forms, fills, and seals theBFS vials.

According to some embodiments, the second process “B” may comprise anadministration process. In some embodiments, the second process “B”and/or the method 900 may comprise activating a unit of the fluiddelivery manifold system, at 908. A third axial force may be applied toaxially compress a unit comprising a mated pairing of a BFS vial, afluid delivery hub, an administration member, a seal, and a safety cap,for example, thereby causing an activation thereof. The third axialforce may cause the administration member to pierce a seal of the BFSvial, for example, and/or may cause the fluid seal to become seatedand/or coupled to the fluid delivery hub. According to some embodiments,the activating may comprise removing the unit from the respectivepackage and manifolds, such as by application of a twisting, shear,and/or rotational force thereto (e.g., with respect to the other unitsof the assembled fluid delivery manifold system).

In some embodiments, the method 900 may comprise removing the safety capof the unit, at 910. Axial separation force may be applied to separatethe safety cap from the fluid delivery hub of the unit, for example,exposing the administration member such as a needle, nozzle, dropper, orthe like. According to some embodiments, the method 900 may compriseadministering a dose of fluid, at 912. The administration element of theunit may be engaged with a patient, for example, and a collapsibleand/or integral reservoir of the BFS vial may be squeezed (e.g., viaapplication of inward radial force) to force fluid therefrom. Accordingto some embodiments, the fluid may be forced in an antegrade axialdirection such that it displaces a valve flap of a one-way valve,thereby allowing the fluid to proceed axially into the administrationelement and be delivered to the patient. In some embodiments, the method900 may comprise replacing the safety cap, at 914. According to someembodiments, the method 900 may comprise disposing of the unit, at 916.In such a manner, for example, a low-cost, easily transported and moreeasily manufactured, assembled, and stored fluid delivery system may beprovided that allows unskilled users to administer and/orself-administer various fluids such as medical and/or therapeuticsubstances.

IV. Rules of Interpretation

Throughout the description herein and unless otherwise specified, thefollowing terms may include and/or encompass the example meaningsprovided. These terms and illustrative example meanings are provided toclarify the language selected to describe embodiments both in thespecification and in the appended claims, and accordingly, are notintended to be generally limiting. While not generally limiting andwhile not limiting for all described embodiments, in some embodiments,the terms are specifically limited to the example definitions and/orexamples provided. Other terms are defined throughout the presentdescription.

Numerous embodiments are described in this patent application, and arepresented for illustrative purposes only. The described embodiments arenot, and are not intended to be, limiting in any sense. The presentlydisclosed invention(s) are widely applicable to numerous embodiments, asis readily apparent from the disclosure. One of ordinary skill in theart will recognize that the disclosed invention(s) may be practiced withvarious modifications and alterations, such as structural, logical,software, and electrical modifications. Although particular features ofthe disclosed invention(s) may be described with reference to one ormore particular embodiments and/or drawings, it should be understoodthat such features are not limited to usage in the one or moreparticular embodiments or drawings with reference to which they aredescribed, unless expressly specified otherwise.

Devices that are in communication with each other need not be incontinuous communication with each other, unless expressly specifiedotherwise.

A description of an embodiment with several components or features doesnot imply that all or even any of such components and/or features arerequired. On the contrary, a variety of optional components aredescribed to illustrate the wide variety of possible embodiments of thepresent invention(s). Unless otherwise specified explicitly, nocomponent and/or feature is essential or required.

Further, although process steps, algorithms or the like may be describedin a sequential order, such processes may be configured to work indifferent orders. In other words, any sequence or order of steps thatmay be explicitly described does not necessarily indicate a requirementthat the steps be performed in that order. The steps of processesdescribed herein may be performed in any order practical. Further, somesteps may be performed simultaneously despite being described or impliedas occurring non-simultaneously (e.g., because one step is describedafter the other step). Moreover, the illustration of a process by itsdepiction in a drawing does not imply that the illustrated process isexclusive of other variations and modifications thereto, does not implythat the illustrated process or any of its steps are necessary to theinvention, and does not imply that the illustrated process is preferred.

The present disclosure provides, to one of ordinary skill in the art, anenabling description of several embodiments and/or inventions. Some ofthese embodiments and/or inventions may not be claimed in the presentapplication, but may nevertheless be claimed in one or more continuingapplications that claim the benefit of priority of the presentapplication. Applicants intend to file additional applications to pursuepatents for subject matter that has been disclosed and enabled but notclaimed in the present application.

It will be understood that various modifications can be made to theembodiments of the present disclosure herein without departing from thescope thereof. Therefore, the above description should not be construedas limiting the disclosure, but merely as embodiments thereof. Thoseskilled in the art will envision other modifications within the scope ofthe invention as defined by the claims appended hereto.

While several embodiments of the present disclosure have been describedand illustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and/or structures for performing thefunctions and/or obtaining the results and/or one or more of theadvantages described herein, and each of such variations and/ormodifications is deemed to be within the scope of the presentdisclosure. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present disclosure is/are used.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the disclosure described herein. It is, therefore, to beunderstood that the foregoing embodiments are presented by way ofexample only and that, within the scope of the appended claims andequivalents thereto, the disclosure may be practiced otherwise than asspecifically described and claimed. The present disclosure is directedto each individual feature, system, article, material, kit, and/ormethod described herein. In addition, any combination of two or moresuch features, systems, articles, materials, kits, and/or methods, ifsuch features, systems, articles, materials, kits, and/or methods arenot mutually inconsistent, is included within the scope of the presentdisclosure.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Other elements may optionallybe present other than the elements specifically identified by the“and/or” clause, whether related or unrelated to those elementsspecifically identified, unless clearly indicated to the contrary.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

Various modifications of the invention and many further embodimentsthereof, in addition to those shown and described herein, will becomeapparent to those skilled in the art from the full contents of thisdocument, including references to the scientific and patent literaturecited herein. The subject matter herein contains important information,exemplification and guidance that can be adapted to the practice of thisinvention in its various embodiments and equivalents thereof.

What is claimed is:
 1. A fluid delivery system for delivery of a fluidagent, the fluid delivery system comprising: an individual BFS vialcontaining a single dose of a fluid agent, the BFS vial comprising aradially compressible reservoir containing the single dose of the fluidagent and comprising a cylindrical neck defining a fluid channel incommunication with the radially compressible reservoir and thecylindrical neck comprising at least one mating feature disposed on anexterior surface thereof; a fluid delivery hub defining an interiorvolume having one or more mating features disposed on an interiorsurface therein, and each of the one or more mating features beingcoupled to a corresponding at least one mating feature of the BFS vialneck; and an administration member being coupled to the fluid deliveryhub.
 2. The fluid delivery system of claim 1, wherein the administrationmember comprises a needle for at least one of subcutaneous,intramuscular, intradermal, and intravenous injection of the fluid agentinto a recipient.
 3. The fluid delivery system of claim 2, wherein theneedle comprises a length in the range of 0.5 mm to 4 mm.
 4. The fluiddelivery system of claim 2, wherein the needle comprises a length in therange of 4 mm to 15 mm.
 5. The fluid delivery system of claim 2, whereinthe needle comprises a length in the range of 15 mm to 30 mm.
 6. Thefluid delivery system of claim 1, wherein the BFS vial comprises anelectronic device storing data descriptive of the fluid agent.
 7. Thefluid delivery system of claim 6, wherein the electronic devicecomprises a Near-Field-Communication (NFC) device.
 8. The fluid deliverysystem of claim 7, wherein the NFC device is operable to facilitateprocessing of data defining the geographical movement of the BFS vial.9. The fluid delivery system of claim 7, wherein the NFC device isoperable to facilitate processing of data that allows a verificationthat the BFS vial is authorized for administration to a particularrecipient.
 10. The fluid delivery system of claim 1, wherein the atleast one mating feature disposed on the exterior surface of thecylindrical neck of the BFS vial comprises a radial flange and whereinthe one or more mating features disposed on the interior surface of thefluid delivery hub comprises a radial channel.
 11. The fluid deliverysystem of claim 1, wherein the administration member comprises a needlecomprising a point on each end thereof.
 12. The fluid delivery system ofclaim 11, wherein the BF S vial comprises a fluid seal that is integralto a terminus of the BFS vial cylindrical neck, and wherein the matingof the BFS vial with the fluid delivery hub positions one of the needlepoints to pierce the fluid seal of the BFS vial.
 13. The fluid deliverysystem of claim 1, further comprising: a safety cap coupled to the fluiddelivery hub such that it shields a distal point of the administrationmember.
 14. The fluid delivery system of claim 13, wherein axial forceapplied to the safety cap causes a proximate point of the administrationmember to pierce a fluid seal formed at a terminus of the cylindricalneck of the BFS vial.
 15. A fluid delivery system for delivery of asingle dose of a fluid agent, the fluid delivery system comprising: anindividual blow fill seal (BFS) vial containing a single dose of a fluidagent in a fluid reservoir and defining a cylindrical neck in fluidcommunication with the fluid reservoir and comprising a fluid seal at anend thereof and comprising an exterior radial flange on an exteriorsurface thereof; an annular plastic element retaining anaxially-oriented needle comprising a first piercing tip at a first endthereof and a second piercing tip at a second end thereof; a safety capdefining a lower void in which the annular plastic element and thesecond piercing tip of the needle are disposed; and a fluid delivery hubdefining an interior volume comprising a radial channel disposed on aninterior surface therein and a passage disposed axially therethrough,the needle being coupled through the passage and the first piercing tipthereof extending into the interior volume such that an axial engagementof the safety cap causes the annular plastic element to exert axialforce upon the fluid delivery hub, thereby mating the exterior radialflange with the radial channel and causing the first piercing tip of theneedle to pierce the fluid seal of the cylindrical neck.
 16. The fluiddelivery system of claim 15, wherein the needle is configured for atleast one of subcutaneous, intramuscular, intradermal, and intravenousinjection of the fluid agent into a recipient.
 17. The fluid deliverysystem of claim 16, wherein the needle comprises a length in the rangeof 0.5 mm to 4 mm.
 18. The fluid delivery system of claim 15, whereinthe exterior radial flange comprises a rounded flange.
 19. The fluiddelivery system of claim 15, wherein the radial channel of the interiorvolume of the fluid delivery hub comprises a rounded channel.
 20. Thefluid delivery system of claim 19, wherein the radial channel comprisesa first radial channel and the radial flange comprises a first radialflange, and wherein the BFS vial further comprises a second exteriorradial flange and wherein the fluid delivery hub comprises a secondradial channel disposed on the interior surface therein, and wherein theBFS vial further comprises a fluid seal that is integral to a terminusof the BFS vial cylindrical neck, and wherein the mating of the BFS vialwith the fluid delivery hub positions one of the needle points to piercethe fluid seal of the BFS vial.